Normativa UEMay. 4, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para propyzamide
Propyzamide was included in Annex I to Directive 91/414/EEC on 01 April 2004, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Sweden, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 29 October 2008 and, after having considered several comments made by EFSA, the RMS provided on 20 October 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC, on the previous reasoned opinion of EFSA and the additional information provided by the RMS, EFSA issued on 08 November 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 20 January 2011 were considered for finalisation of this reasoned opinion.
The following conclusions are derived.
The toxicological profile of propyzamide was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.02 mg/kg bw/d. An ARfD was not deemed necessary.
Primary crop metabolism of propyzamide was investigated following foliar application in lettuce, alfalfa and winter rape, which only covers two groups of crops (leafy crops and pulses & oilseeds).
Metabolic patterns in those different studies were shown to be similar. Since propyzamide is mainly applied during early growth stages of the crop or during dormancy (soil applications), rotational crop studies (carrot, lettuce and wheat) have been be taken into account to complete the assessment of the metabolic pathway of propyzamide. It was concluded that the pattern of metabolites is comparable with the metabolites observed in primary crops. Hence, the relevant residue for enforcement and risk assessment in all crops supported in the framework of this review was defined as parent propyzamide. A validated analytical method for enforcement of this residue definition with a LOQ of 0.01 mg/kg in all plant commodities is available.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials is available for most of the GAPs reported by the RMS. This allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs. For herbal infusion (dried roots) (where validated analytical methods are still required), lettuce and other salad plants (where further residue data are still required) and dry peas, dry beans and lentils (where storage stability data is still required), only tentative MRLs were calculated. For leek, hops and other herbal infusion (dried leaves and dried flowers), no MRLs were derived because no data are available. As no residue data in sugar beet leaves were available, no MRL was derived for this feed item either.
The effect of industrial and/or household processing was not investigating during the peer review but was not considered necessary since chronic exposure represents much less than 10% of the ADI.
Occurrence of propyzamide residues in rotational crops was investigated during the peer review of propyzamide. In order to avoid propyzamide residues in rotational crops it is recommended that the Member States before granting an authorization for the use of propyzamide should consider the need for establishing plant back intervals for rotational crops that have short vegetation periods.
Based on the uses reported by the RMS, significant intakes were calculated for ruminants and pigs. Metabolism in ruminants and hens was sufficiently investigated but findings cannot properly be extrapolated to pigs because of the incertitude on the comparability of the metabolic profiles in rat and ruminant. However, as all metabolites in both rat and goat containing the 3,5-dichlorobenzoic acid moiety, the relevant residue definition for enforcement and risk assessment in all animal commodities was defined as the sum of propyzamide and all metabolites containing the 3,5-dichlorobenzoic acid moiety, expressed as propyzamide. An analytical method for enforcement of this residue definition in meat, fat, liver and kidney with a combined LOQ of 0.01 mg/kg in meat and fat and 0.1 mg/kg in liver and kidney is available. This method converts all metabolites to the 3,5-dichlorobenzoic acid moiety and is therefore suitable for the proposed residue definition. However, an ILV and a confirmatory method are still required to confirm its validity. Consequently, available studies only permitted to derive tentative MRLs (at the LOQ) in ruminant and pig commodities (also including milk).
Chronic consumer exposure resulting from the uses supported in the framework of this review was calculated. The highest chronic exposure for propyzamide was calculated for UK toddlers, representing 2.5% of the ADI. Acute exposure calculations were not carried out because an ARfD was not deemed necessary.
• Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D (see table below for a summary). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnotes for details). In particular, certain tentative and existing MRLs still need to be confirmed by the following data:
• a study investigating storage stability of propyzamide in dry commodities;
• a validated analytical method for enforcement of propyzamide residues in hops and herbal infusions (dried leaves, dried flowers, dried roots);
• a confirmation that the residue trials on lettuce were carried out on open leaf varieties;
• 4 residue trials on lettuce complying with the northern outdoor GAP for lettuce and scarole;
• 8 residue trials supporting the Portuguese GAP on leaves and sprouts of brassica spp;
• 8 residue trials on leek complying with the northern outdoor GAP;
• 4 residue trials on crops representative for the GAP on dried leaves herbal infusion in both northern and southern zone;
• 4 residue trials on crops representative for the GAP on dried flowers herbal infusion in both northern and southern zone;
• 4 residue trials (at least) complying with the northern outdoor GAP on hops;
• a confirmatory method and an ILV for the enforcement of propyzamide residues (including its metabolites) in animal products.
It is highlighted that some of the ‘Recommended’ MRLs result from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the recommended MRLs but which might have an impact on national authorisations:
• 8 residue trials on apples and/or pears (with a minimum of 4 trials on apples) complying with the Italian GAP for apples and pears;
• 8 residue trials table and/or wine grapes complying with the Italian GAP;
• 4 residue trials on sugar beet tops complying with the southern outdoor GAP;
• 2 residue trials on alfalfa complying with the southern GAP.
If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. For sugar beets in particular, Member States should establish appropriate restrictions in order not to feed livestock with treated sugar beet leaves.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the ‘Recommended’ MRLs or on the national authorisations. The following actions are therefore considered desirable but not essential:
• a confirmation that residues trial samples were stored according to the demonstrated storage stability conditions;
• 4 trials on apples complying with the southern outdoor GAP for apples, pears and stone fruits;
• additional residue trials on cucumber complying with the northern GAP, carried out with an LOQ of 0.01 mg/kg;
• additional residue trials on cardoons complying with the southern GAP, carried out with an LOQ of 0.01 mg/kg;
• additional residue trials on artichoke complying with the northern GAP, carried out with an LOQ of 0.01 mg/kg;
• a validation of the hydrolysis step for the analytical method for enforcement of residues in food of animal origin;
• a study investigating storage stability of propyzamide residues (including its metabolites) in commodities of animal origin.